40-patient breast cancer study concludes for Radiopharm

Radiopharm Theranostics’ fight against cancer has taken a vital step forwards after the completion of a phase 1 imaging study of 40 breast cancer patients in Shanghai. According to the company, the procedure delivered uniformly excellent and easy to interpret results. Radiopharm is now looking to accelerate the development of its “RAD201” cancer fighting process and fire up a new therapy study for its RAD202 biotechnology.

RAD201 is a novel, single domain antibody engineered to bind the imaging isotope, which targets a protein entitled the human epidermal growth factor receptor, or “HER2” that is often linked to breast cancer. Radiopharm says that HER2 overexpression in breast cancer is frequently linked with aggressive disease and subsequently poor prognosis.

The company’s latest study was conducted at the Shanghai General Hospital and was spearheaded by Dr Jinhua Zhao, who imaged 40 microscopically or “histopathologically” proven breast cancer subjects.

The procedure involved injecting a patient with RAD201, allowing the single domain antibody to localize at the HER2 positive cancer, then imaging the subject using a single photon emission computed tomography or “SPECT” camera.

According to the company, the images were consistently excellent and easy to interpret, potentially earmarking the RAD201 SPECT imaging process as a rapid and non-invasive mechanism in gaining insight into HER2 overexpression in primary and secondary breast cancer.

Shanghai General Hospital Director of Nuclear Medicine, Jinhua Zhao said:“The images obtained were outstanding with this novel radiotracer, 99m Tc-anti HER2 single domain antibody SPECT/CT, and can provide clinicians with much more holistic and useful information on HER2 expression in both primary and metastatic neoplasms in breast cancers than the conventional IHC method of assessing HER2 expression. These preliminary results are very encouraging for planning further studies to explore the potential of this single domain antibody in theranostics applications.”

The company says following its “encouraging” results, it will now power ahead with the development of RAD201 and launch a Phase 1 therapy study for RAD202 as a company-sponsored Investigational New Drug recognised by the US Food and Drug Administration or “FDA”. According to Radiopharm, RAD202 is set to be comprised of the same single domain antibody construct as its predecessor, RAD201, but importantly, it will also take in the therapeutic, beta particle-emitting isotope, Re-188 that could kill cancer cells.

Radiopharm only listed on the ASX a few weeks ago and is one of a string of biotechs and biotechnologies to be brought to market by its Executive Chairman Paul Hopper.

Hopper’s resume includes the founding of clinical stage immuno-oncology company Imugene, which is now approaching a market cap of $3b. He also founded fellow ASX-listed Chimeric Therapeutics and holds boardroom positions at Prescient, Polynoma and Suda Pharmaceuticals.

The public biopharmaceutical space has been on a tear since COVID-19 stopped the world in its tracks and Radiopharm is one of a string of listed companies that are forming the tip of the spear in the fight against cancer.

Is your ASX-listed company doing something interesting? Contact: matt.birney@businessnews.com.au